Stimwave Technologies Incorporated - FDA 510(k) Cleared Devices
Recent clearances: Freedom Spinal Cord Stimulator (SCS) System, Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Stimwave Technologies Incorporated Neurology ✕
8 devices
Cleared
Mar 29, 2019
Freedom Spinal Cord Stimulator (SCS) System
Neurology
182d
Cleared
Sep 19, 2018
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
Neurology
159d
Cleared
Nov 03, 2017
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with...
Neurology
63d
Cleared
May 02, 2017
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable...
Neurology
105d
Cleared
Dec 16, 2016
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable...
Neurology
136d
Cleared
Aug 26, 2016
Freedom Spinal Cord Stimulator System
Neurology
177d
Cleared
Jun 05, 2015
Freedom Spinal Cord Stimulator System
Neurology
95d
Cleared
Oct 10, 2014
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
Neurology
135d